DEGANIA SILICONE SIL-K— 510(k) K971482

Substantially Equivalent

Degania Silicone , Ltd.

FDA 510(k) clearance K971482 for DEGANIA SILICONE SIL-K, Substantially Equivalent on 1997-06-24. Applicant: Degania Silicone , Ltd.. Device class: 1.

Clearance details

Applicant: Degania Silicone , Ltd.
Product code: Code MDA
Device class: Class 1
Regulation: 21 CFR 878.4025
Advisory panel: General, Plastic Surgery
Date received: 1997-04-21
Decision date: 1997-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Emek Hayarden, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.